Trial Outcomes & Findings for Effect of Rosuvastatin on Endothelial Function (NCT NCT00986999)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

7 participants

Primary outcome timeframe

3 months

Results posted on

2015-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Rosuvastatin rosuvastatin 10 mg qd increased to 20 mg qd as tolerated rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Rosuvastatin on Endothelial Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rosuvastatin n=7 Participants rosuvastatin 10 mg qd increased to 20 mg qd as tolerated rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Not analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

Adverse Events

Rosuvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cecilia M. Shikuma M.D.

University of Hawaii

Phone: 808 692-1328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place